Environmental Controls Lead

About the job

Job Summary

The Environmental Monitoring Data Scientist is primarily responsible for leading the completion of projects and tasks directly or indirectly supporting key initiatives and functions within the Environmental Monitoring Department. The main responsibilities include but are not limited to leading the Environmental Controls team in data integrity and organization, routine reporting and analysis, and identification and development of process improvements.



· Continue to support routine environmental monitoring of air, surface, and clean utilities for manufacturing of in-process and final product drug lots for customers.

· Ensure data is efficiently processed while maintaining data integrity.

· Compile and analyze all EM data for routine reporting and provide support to cost-impacting investigations, customers, senior leadership, and process improvements.

· Analyze data to identify issues and potential sources, i.e., trends, and work with leaders and team members to create proactive solutions.

· Develop and execute protocols to ensure current processes are in compliance with regulatory auditing and SOP standards.

· Present data using various visualization techniques and tools.

· Develop EM department compatibility with overall facility resources, i.e., MasterControl, LIMS, to boost general performance.

· Support operations and quality assurance with representative EM data and feedback for ongoing cleanroom process improvements.

· Implement and maintain control charts for EM data.

· Utilize data to analyze and update EM limits.

· Utilize data to identify trends and take action to limit OOS results. • Incorporate data into EM reports for internal and regulatory review.

Set yourself apart

Set Yourself Apart: Profile/Experiences

· Requires a BS and 1-2 years of cleanroom experience in environmental monitoring operations.

· Minimum of 1 year experience in data/statistical/process analysis, preferably in environmental monitoring.

· Ability to gown and gain access to cleanroom areas.

· Proficient in Microsoft Office and statistical analysis tools and charts.

· Excellent technical writing, scientific method, and communication skills.

· Ability to work in a fast-paced environment and manage multiple objectives for on-time completion.

· Must work well on a team and be able to problem solve in a cross functional team.

What’s on offer?

Fagron offers exciting opportunities for personal and professional growth, which supports and encourages you to develop your skills and talents. Be part of a collaborative culture that rewards you with competitive compensation, an extensive benefits package and a truly open and dynamic work environment.

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